Study Phase 3

A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

  • 1 CSR Summary Not Available
  • 1 NCT03434041
  • 1 Primary Citation Trial has yet to be published
  • Data Specification Not Available

Trial Information

Generic NameEsketamineProduct NameSPRAVATO®Therapeutic AreaNervous System DiseasesEnrollment252% Female44.8%% White8.3%
Product ClassNMDA receptor antagonistSponsor Protocol NumberESKETINTRD3006Data PartnerJohnson & JohnsonCondition StudiedDepressive Disorder, Treatment-ResistantMean/Median Age (Years)37.3

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.